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Curtis Wright

Dopesick

Curtis Wright was the U.S. Food and Drug Administration examiner who led the 1995 review that approved OxyContin. His role matters because the application he signed off on recorded important risks of misuse, while his approval summary urged caution about promotion; two years later, he went on to work as a consultant for Purdue Pharma. The book presents this sequence through Art Van Zee’s explanation of the approval process to Barbara Van Rooyan, whose son had died after taking OxyContin.

Identity and Role

Wright was the agency’s top examiner leading the review of Purdue Pharma’s New Drug Application for OxyContin. The application, filed in 1995, provided the documentary basis for Van Zee’s account of what regulators knew when the drug was approved. Van Zee had a copy of the application, which Sue Ella Kobak had given him as a Christmas present in 2000, and used it to explain the approval to Van Rooyan.

Risks in the Application

The review described how crushing the tablets could cause the drug to be released immediately rather than in a controlled manner. It also recorded withdrawal symptoms in several patients during clinical trials. In addition, the application stated that 68 percent of the oxycodone in a single crushed pill could be recovered when the material was liquefied and injected. These details made the later public claim by Purdue Pharma that it had not known of OxyContin’s abuse problems until February 2000 difficult to reconcile with the information in the 1995 filing.

Promotion and Later Work

In his summary of the approval, Wright advised that care should be taken to limit competitive promotion. The book sets that warning against what followed: in practice, little care was taken in promoting the drug. Wright’s subsequent work as a Purdue Pharma consultant, beginning two years after the approval review, adds a further connection between the regulator who had reviewed the application and the company marketing the product. The account establishes the sequence and its tension without claiming what motivated Wright’s later work.